Versant HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Premarket Approval P160016 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To change plastic resin used in non-critical component vials

• Device: Versant HCV Genotype 2.0 Assay (LiPA)
• Classification Name: Assay, Genotyping, Hepatitis C Virus
• Generic Name: Assay, Genotyping, Hepatitis C Virus
• Applicant: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
• Date Received: 2019-07-25
• Decision Date: 2019-09-20
• PMA: P160016
• Supplement: S004
• Product Code: OBF
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SIEMENS HEALTHCARE DIAGNOSTICS, INC. p.o. Box 2466 berkeley, CA 94702-2466

Supplemental Filings

Supplement Number	Date	Supplement Type
P160016		Original Filing
S006	2020-07-31	30-day Notice
S005
S004	2019-07-25	30-day Notice
S003	2019-03-08	30-day Notice
S002
S001	2018-01-02	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00630414602882	P160016	000
00630414602875	P160016	000
00630414000534	P160016	000
00630414000510	P160016	000
00630414000503	P160016	000
00630414000497	P160016	000